Regulatory & Clinical Affairs Officer

Reed work closely within the Pharmaceutical and Medical Device market places to create a smooth process for uniting candidates with essential skills sets to the organisations who will be best fuel their ambition and drive them to make the biggest impact on their employers‘ operations. A specific requirement has arisen with a leading global brand in the medical device market place for an experienced professional with outstanding knowledge and experience in regulation and Clinical Affairs advising.to join the centre for the companies European operations, based in Prague, Czech Republic.

This international brand operates across a wide range of distribution channels with an even wider portfolio or self-developed, innovation device solutions for the global medical marketplace. Due to recent structural realignments, this is the perfect time to join the company if you are an ambitious, international minded and commercially aware profession hoping to find limitless career opportunities within both local and global markets, all supported by an outstanding international brand and comprehensive, efficient support structure.

The role shall report to a locally based Quality & Regulations manager in Prague and remotely to an EMEA regional operations and clinical affairs manager and shall take responsibility for the regulation, registration and development of their existing medical device portfolio and market approach and distribution regulation for new devices. Some specific role expectations can be found below, but if you have experience in Regulation and are up to date with Clinical Affairs in the medical device network, no matter what level of seniority your previous experience is at, please get in touch.

Job description
Regulatory & Clinical Affairs Officer CEE
Report to:
• Manager Regulatory and Clinical Affairs Market EMEA— RCA (Pre-Market activities)
• Q&R Manager Market CEE (for Post Market activities)

Aim of the job: This position intends to support Regulatory & Clinical Affairs activities, acting on behalf of the Quality & Regulatory Market Lead and the Manager Regulatory & Clinical Affairs within the Market CEE where necessary.
Under the responsibility of the Regulatory & Clinical Affairs Officer CEE the candidate shall:
• Support Vigilance Reporting with Competent Authority for the assigned countries.
• Manage and/or supports product registrations (NPI or Renewals) to Competent Authorities.
• Monitor Mandatory FCO/FSN completion and ensure regulatory communication is executed in a timely manner.
• Supports Clinical Evaluations initiated by the Sponsor (usually the BlU).
• Ensure compliance with the applicable country regulations and PH standards & policies.

Key Areas of Responsibility
Regulatory Administration
• Supports tracking of related KPIs to ensure Compliance for the Market CEE.
• Filling the License database with planned registration actions and existing certificates.
• Monitor expiry date and supervise distributor to this.
Post-Market Surveillance Vigilance (reportable complaints or other regulatory cases)
• Supports any required filings for Medical Device and Safety Vigilance Reports within the defined time to Regulatory Agencies/Competent Authority.
• Performs communication internally with Philips BIU’s in regard to reported incidents.
• Tracks status of reported incidents with Competent Authority ensuring all cases are closed by CA following adequate submission of objective evidence.
Product Registrations
• Ensures country/ district Medical Product Approvals process and submissions when relevant (excluding 510K and CE Medical marking under BIU responsibility) — product notification and registration, if applicable, as per local countries requirement
• Supports the solid Line manager and the dotted Line Manager in preparing product registration documentation
• Coordinates with Competent Authorities and/ or Authorized Representative/Distributor for product Registrations
• Tracks status of current and new product registrations Recall & Correction Management
• Executes communication package localization. Proposes/executes 1 Customer/Competent Authority communication
• Tracks product recalls for Mandatory field change orders (FCOs) to closure
• Communicates with channel partners and BIU’s on MA FCO completion
Regulatory Affairs Management
• Assists public relations efforts on regulatory issues, i.e. governmental efforts, Regulatory Warning letters and product recalls
• Supports the solid Line manager and the dotted Line Manager in representing Philips in country government & regulatory agencies to include medical device, environmental, nuclear, and other regulatory bodies.
• Acts on behalf of solid Line manager and the dotted Line Manager as Philips regulatory representative at assigned regional/country trade or industry associations
• Keep aware of Regulatory requirements changes impacting the assigned country districts
• Any other activities supporting Philips Healthcare as assigned by the Managers.
Back up responsibilities
• Customer Feedback System Administration
• Access rights management
• Track and maintain the Customer Feedback Tracker
• Assigns feedback owners according to defined criteria
• Validates feedback closure according to defined criteria
• Request further investigation by the BU on feedback / Incident

Hospitals, medical practice activities, other human health activities

Reed work closely within the Pharmaceutical and Medical Device market places to create a smooth process for uniting candidates with essential skills sets to the organisations who will be best fuel their ambition and drive them to make the biggest impact on their employers‘ operations. A specific requirement has arisen with a leading global brand in the medical device market place for an experienced professional with outstanding knowledge and experience in regulation and Clinical Affairs advising.to join the centre for the companies European operations, based in Prague, Czech Republic.